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FDA Rescinds Juul Ban, Opening Door for Federal Clearance
The Wall Street Journal· 1 hour agoThe FDA said its decision on Juul’s appeal was made in part because of new case law that has been ...
US FDA rescinds market denial order for Juul products
WSAU Wausau· 24 minutes ago(Reuters) - The U.S. Food and Drug Administration (FDA) said on Thursday it was rescinding a June...
Juul e-cigarettes’ FDA ban lifted
Market Watch· 1 hour agoThe move does not authorize or deny Juul’s applications but returns them to pending status, the FDA said. The decision comes after new case law was ...
First salvo fired against FDA’s laboratory developed test rule | JD Supra
JD Supra· 10 hours agoLast month, FDA finalized its landmark proposed rule that would amend the definition of “in vitro diagnostic (IVD) products” in 21 CFR 809.3, effective May 6, 2024, to make ...
Lawsuit Filed Challenging FDA Final Rule Regulating Laboratory Developed Tests | JD Supra
JD Supra· 3 days agoAs detailed in our prior analysis (here), the final rule amended the FDA’s existing regulations to make explicit the agency’s interpretation that LDTs are “devices” under ...
FDA approves Moderna’s RSV vaccine mRESVIA
Pharmaceutical Technology via Yahoo Finance· 3 days agoModerna CEO Stéphane Bancel stated: “The FDA approval of our second product, mRESVIA, builds on the strength and versatility of our mRNA platform....
Be Bio’s haemophilia B treatment gains FDA orphan drug status
Pharmaceutical Technology via Yahoo Finance· 1 day agoIt confers benefits such as seven years of exclusive marketing rights post-approval, exemption from ...
U.S. Senate GOP prevents contraception access bill from moving ahead
Pennsylvania Capital-Star via Yahoo News· 20 hours agoDemocrats argued during debate on the 12-page bill that it would provide a safety net should a...
FDA Gets Technical on HCT/P Rules in Warning Letter to Human Tissue Company
The National Law Review· 6 days agoOn May 21, 2024, the Center for Biologics Evaluation and Research (CBER) at the U.S. Food and Drug...
FDA clears InnoVoyce’s VYLO Laser System for medical use
Medical Device Network via Yahoo Finance· 6 days agoInnoVoyce CEO Michael Davin said: “InnoVoyce was established with a mission to introduce innovative...
